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NCT00520364 · ClinicalTrials.gov registry record

In Vitro Fertilization and Pregnancy After Use of Chemotherapy

A clinical trial, sponsored by New York Medical College.

Terminated
Registry status
100
Enrollment target

NCT00520364 is a clinical trial that was terminated before completion, run by New York Medical College. The registered enrollment target is 100 participants.

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The verdict

NCT00520364 was terminated before completion, sponsored by New York Medical College.

TERMINATED
Registry status
100 participants
Enrollment target

Study Summary

Objective: Chemotherapy regimens containing alkylating agents result in primordial follicle death and premature ovarian failure. Depending on the age and the type/dose of chemotherapy, some women may continue to menstruate. Our aim was to ascertain the impact of chemotherapy on ovarian reserve in patients who previously received chemotherapy by response to controlled ovarian hyper stimulation (COH) and anti-mullerian hormone (AMH) levels. Design: Prospective study with retrospective controls Materials and Methods: 45 cancer patients underwent controlled ovarian stimulation for IVF before (30 patients, 30 IVF cycles) or after (15 patients, 30 IVF cycles) chemotherapy. Patients with basal serum FSH \>13mIU/mL or E2\>70pg/ml were excluded. AMH was measured on previously stored serum samples from the day of initiation of the ovarian stimulation. Results: Mean ages and baseline FSH levels of pre- and postchemotherapy IVF patients were similar (36.8±0.91 vs. 36.3±1). The mean interval from completion of chemotherapy to IVF was 8.03±1.32 years (range 1-23). Of the 30 IVF cycles in post-chemotherapy patients, 22 received alkylating agents and 8 did not. There were no significant differences between the study and control cycles regarding day-2 estradiol (E2), length of stimulation, total gonadotropin dose, and E2 on hCG day (table 2). Cycle cancellation rate was 20% and 26.67% for pre and post-chemotherapy patients, respectively. The number of oocytes retrieved and fertilized were significantly higher in pre-chemotherapy group (p\<0.0001). Two clinical pregnancies were achieved in the postchemotherapy group, one ending in spontaneous abortion and the other in the delivery of a healthy baby (6.67% clinical pregnancy rate and 3.33% delivery rate per attempted cycle). All fertilized oocytes in the control group were cryopreserved at 2-pronuclei stage. Baseline AMH levels were significantly lower in post chemotherapy IVF patients compared to those who underwent IVF prior to ch

Interventions

  • OTHER Observation of IVF outcomes in relation to chemo history and AMH

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2014-09-15
Est. Completion 2018-05-30

Sponsor

New York Medical College

47 total trials

What the Registry Record Tells You About NCT00520364

The ClinicalTrials.gov registry entry for NCT00520364 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York Medical College, which has 47 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Observation of IVF outcomes in relation to chemo history and AMH is the first listed.

NCT00520364 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00520364 about?

NCT00520364 is a clinical study titled "In Vitro Fertilization and Pregnancy After Use of Chemotherapy". Objective: Chemotherapy regimens containing alkylating agents result in primordial follicle death and premature ovarian failure. Depending on the age and the type/dose of chemotherapy, some women may continue to menstruate. Our aim was to ascertain the impact of chemotherapy on ovarian reserve in pa...

What is the current status of trial NCT00520364?

This trial is currently terminated. The enrollment target is 100 participants. The study started on 2014-09-15. Estimated completion is 2018-05-30.

What interventions are being tested in trial NCT00520364?

The interventions under investigation include: Observation of IVF outcomes in relation to chemo history and AMH (OTHER).

Who is sponsoring clinical trial NCT00520364?

This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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